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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 14, 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: "Apparisal of Safety of chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO)
Deviations:
no
GLP compliance:
no
Remarks:
pre GLP

Test material

Constituent 1
Reference substance name:
Acid Blue 025
IUPAC Name:
Acid Blue 025
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
other: Russian
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.0 - 2.3 kg
- Housing: individually
- Diet: ad libitum standard rabbit food ( NAFAG Gossau SG)
- Water: ad libitum
- Acclimation period: minimum 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 1°C
- Humidity (%): 55 ± 5%
- Photoperiod (hrs dark / hrs light): Cycle light/dark 14 hs

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved and scarified
Vehicle:
not specified
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
24 hours exposure
Observation period:
7 days
Number of animals:
3 male and 3 female
Details on study design:
TEST SITE
Gauze patches of 2.5 x 2.5 cm covered with an impermeable material and fastened to the body of the rabbit with adhesive tape

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no erythema
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no erythema
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no erythema
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no erythema
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no erythema
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no erythema
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no edema
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no edema
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no edema
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no edema
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no edema
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no edema
Remarks on result:
no indication of irritation

Any other information on results incl. tables

time 24 h 48 h 72 h 4 d 7 d
sex male female male female male female male female male female
Animal n. 88 90 92 69 71 73 88 90 92 69 71 73 88 90 92 69 71 73 88 90 92 69 71 73 88 90 92 69 71 73
erythema a 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
b 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
oedema a 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
b 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
total a 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
b 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
mean a 0 0 0 0 0 0 0 0 0 0
b 0 0 0 0 0 0 0 0 0 0
group mean a 0 0 0 0 0
b 0 0 0 0 0

a = intact skin

b = abraded skin

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
Not irritant
Executive summary:

The substance to be registered has been tested on rabbits according to the patch-test technique described in the AFDO Guideline "Apparisal of Safety of chemicals in Foods, Drugs and Cosmetics" (1959). The test substance was applied on intact and abraded skin. No erythema and no oedema were observed during the test.